Position Overview

We are seeking an experienced and motivated Principal Purification Process Development  Scientist to support our growing ADC pipeline. This role will be responsible for the optimization of purification processes for antibody intermediates (mAbs). The preferred candidate will coordinate and/or execute purification strategies including scale-up to tox/GMP, while demonstrating expertise in practical, robust purification strategies applicable to clinical and commercial-stage manufacturing of mAbs. The ideal candidate will have experience with technology transfer, regulatory compliance, and coordination with CDMO partners at GMP manufacturing facilities. A strong working knowledge of different purification technologies is essential, as is experience with standard analytical and characterization approaches used for biologics.

Responsibilities

• Oversee Purification Process Development strategies, including Design of Experiment (DOE) and One Factor at a Time (OFAT) approaches for critical process parameters.
• Fulfill the role of a purification subject matter expert (SME) on cross-functional CMC teams to ensure alignment on program goals, deliverables, and objectives.
• Collaborate with external CDMO partners to support the Immunome pipeline from pre-clinical, through clinical and commercial stages. Occasional travel to advise and oversee development and GMP manufacturing processes will be expected.
• Prepare essential documentation (SOPs, protocols, and reports) to support tech transfers, GMP activities, and regulatory submissions for clinical development and commercialization.
• Stay current with emerging trends, innovations, and regulatory requirements for mAb purification processes, integrating necessary or potentially beneficial features into our internal company strategies and workflows.

Qualifications

• A Bachelor’s, Master’s, or Ph.D. degree in Chemistry, Chemical/Biochemical Engineering, Biotechnology, or a related field.
• A minimum of 5 years of biotech/biopharma industry experience with a Ph.D., 8 years with a Masters, or 10 years with a Bachelors, with a primary focus on purification process development, or equivalent experience.
• Prior experience with tech transfer, external CDMO engagement, and internal coordination with relevant functions.
• Prior knowledge of/experience working with GMP manufacturers and processes, including familiarity with regulatory submissions.
• Lead/support authoring and reviewing of relevant module 3 sections of regulatory submissions (IND, IMPD, BLA, etc).
• Familiar with laboratory operations and needs for establishing a highly functioning development lab.
• Demonstrated success in developing and optimizing purification processes for monoclonal antibodies and recombinant proteins.
• Experience in regulatory submissions, responding to information requests, and interfacing with health authorities.

Knowledge and Skills

• A strong understanding of the common purification, analytical, and characterization approaches used for mAbs, with a solid foundation in overcoming some of the challenges encountered in these workflows.
• Must be a purification subject matter expert including chromatography separations and filtration operations (depth, dead-end, virus and ultrafiltration/diafiltration).
• Expert user of AKTA chromatographic instruments (such as AKTA Avant, AKTA Ready or similar).
• Design, plan, schedule, organize, prioritize, execute, document and present complex experiments using Design of Experiment (DOE) when needed.
• The ability to manage multiple projects simultaneously while being able to prioritize and balance hands-on tasks with strategic responsibilities.
• Exceptional communication skills, with an emphasis on effective collaborations with both internal stakeholders and external partners.
• High-throughput liquid handling systems (Tecan) experience is a plus.